A laryngectomy is a surgical procedure which involves the removal of a patient's voice box and other surrounding structures, usually for treatment of cancer of the larynx. During the procedure a permanent opening known as a tracheostoma or stoma is created in the patient's neck to allow air intake into the lungs through this opening, rather than through the mouth.
As the patient's voice box has been removed, most patients subsequently undergo a tracheo-oesophageal puncture in order to restore their speech. This involves the creation of a hole (a fistula) between the oesophagus and the trachea. This allows a one-way valve prosthesis to be fitted into this gap. Such valves enable air to pass one way from the lungs/trachea up through the oesophagus. Simultaneously this valve seals the gap in the opposition direction, and prevents leakage of food or saliva from the oesophagus through the trachea to the lungs, a potential source of chest infection.
The valve blocks the flow of secretions and food materials from the oesophagus to the airway, but allows a passage of air from the airway into the throat to permit speech.
Following tracheo-oesophageal puncture surgery, there may be periods of time during which the valve prosthesis is not in place, for example before the new valve is fitted. Alternatively a leaking valve may have to be removed and the fistula tissues ‘rested’ before a new valve can be fitted. When the valve is not in place the fistula must be sealed to prevent leakage of secretions and food materials into the airway which could cause infections. Typically this is done using a Foley's catheter, which is placed through the wound at the front of the neck, through the fistula and down the oesophagus into the stomach. The catheter is also used for feeding the patient.
The Foley's catheter was designed as a urethral catheter to provide continuous urinary drainage from the bladder. A balloon at one end of the catheter is inflated to retain the tip of the catheter in the bladder. When used to seal a tracheo-oesophageal fistula, the end of the Foley's catheter sits in the stomach and the balloon is inflated to prevent the tube moving out the stomach.
Using a Foley's catheter to seal the fistula relies on the tissues surrounding the fistula resting against the surface of the catheter to provide a seal between the oesophagus and trachea. This sometimes works adequately, but not always. The seal provided is sometimes not good enough to allow oral feeding, and when the valve is not in place the patient must be fed through the catheter directly into the stomach. If the seal is not adequate then there is an increased chance of infections as secretions from the oesophagus can leak into the trachea. A foleys catheter is not designed to be used in this way and can be uncomfortable for the patient to wear.
U.S. Pat. No. 4,836,204 describes a method for effecting closure of a perforation in the septum of the heart using a double-balloon catheter. The catheter is designed to be inserted through a vein, into the heart, and through the perforation. Once in place the balloons are inflated either side of the perforation to seal the gap. The other end of the catheter is buried in the patient's subcutaneous tissues and the catheter remains in position until open heart surgery can be carried out to correct the problem.
It would be desirable to provide an improved catheter specifically designed for use in sealing a tracheo-oesophageal fistula.